Devices › Posterior cervical screw system
Device brand name · Orthosis cervical pedicle screw spinal fixation
Ti Locking Screw: medical device reports filed with FDA
422 reports name it, 2012–2022. Manufacturer given most often on reports: Wrights Lane Synthes USA Products. Product code NKG.
- 422
- device reports naming the brand
- 0% of all MAUDE reports · about 30 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 4.3%
- classified as malfunction
- 34.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 422 reports that name the brand "Ti Locking Screw" (orthosis cervical pedicle screw spinal fixation), received between July 2012 and June 2022; the manufacturer given most often on reports is Wrights Lane Synthes USA Products. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (95.7%) and malfunction (4.3%); across all posterior cervical screw system reports (product code NKG) death is recorded in 0.7% and malfunction in 34.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are unintended movement (6.2%), device dislodged or dislocated (3.6%) and migration or expulsion of device (3.3%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, pain and post operative wound infection. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,215 reports carrying product code NKG. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Unintended movement | 26 | 6.2% | 1.9% |
| Device dislodged or dislocated | 15 | 3.6% | 2% |
| Migration or expulsion of device | 14 | 3.3% | 1.1% |
| Loose or intermittent connection | 10 | 2.4% | 0.9% |
| Detachment of device component | 6 | 1.4% | 0.4% |
| Device slipped | 5 | 1.2% | 1.2% |
| Malposition of device | 5 | 1.2% | 0.2% |
| Mechanical problema mechanical problem | 5 | 1.2% | 1.4% |
| Breakthe device broke | 4 | 0.9% | 13.4% |
| Failure to adhere or bond | 4 | 0.9% | 0% |
| Migrationthe device moved from where it was placed | 4 | 0.9% | 13.5% |
| Noise, audible | 3 | 0.7% | 0.3% |
| Detachment of device or device componentpart of the device came off | 2 | 0.5% | 4.1% |
| Manufacturing, packaging or shipping problem | 2 | 0.5% | 0.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.2% | 0.3% |
| Human-device interface problem | 1 | 0.2% | 0% |
| Incomplete or missing packaging | 1 | 0.2% | 0% |
| Insufficient device problem information | 1 | 0.2% | 3% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Appropriate clinical signs, symptoms and conditions term/code not available | 75 | 17.8% |
| Painpain, site not specified | 59 | 14% |
| Post operative wound infection | 48 | 11.4% |
| Failure of implant | 43 | 10.2% |
| Spinal cord injury | 35 | 8.3% |
| Intervertebral disc compression or protrusion | 28 | 6.6% |
| Impaired healingslow healing | 25 | 5.9% |
| Stenosis | 25 | 5.9% |
| Nonunion/delayed-union bone fracture | 21 | 5% |
| Hypersensitivity/allergic reaction | 19 | 4.5% |
| Fatiguetiredness | 16 | 3.8% |
| Chillschills or shivering | 12 | 2.8% |
| Neuropathy | 12 | 2.8% |
| Positive antinuclear antibodies (ana) | 12 | 2.8% |
| Rashskin rash | 12 | 2.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ti Locking Screw | Product code NKG | All MAUDE reports |
|---|---|---|---|
| Reports | 422 | 2,215 | 26,136,888 |
| Share of that pool | — | 19.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 7 | 9 |
| Classified as injury | 95.7% | 65% | 36.2% |
| Classified as malfunction | 4.3% | 34.3% | 62.3% |
| Filed by the manufacturer | 100% | 98.2% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code NKG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown_Spine_Product | 596 | 24 | 0% |
| Unknown K2m Product | 269 | 37 | 0% |
| Symphony | 1,163 | 133 | 1.6% |
| Stardrive Screwdriver Shaft T8 105mm | 329 | 43 | 0% |
| Vertex Reconstruction System | 759 | 9 | 0.3% |
| Unknown Cage/Spacer | 280 | 4 | 0% |
| UNK - Constructs: Plate/Screws | 850 | 9 | 0% |
| Unknown Screw/Rod Construct Accessories | 296 | 0 | 0% |
| Invictus | 167 | 0 | 0% |
| Star | 520 | 50 | 0% |
| Unk - Screws | 256 | 0 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Ti Locking Screw reports
How many FDA reports name Ti Locking Screw?
422 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (95.7%) and malfunction (4.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unintended movement (6.2%), device dislodged or dislocated (3.6%), migration or expulsion of device (3.3%), loose or intermittent connection (2.4%) and detachment of device component (1.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Ti Locking Screw was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.